The EMA has accepted Inspiration Biopharmaceuticals' marketing app for its new treatment for hemophilia B, triggering a $35 million milestone payment from its European partner Ipsen. The French company says it expects to see a formal European approval in late 2012.
Just a few weeks ago Ipsen and Inspiration announced plans to create a commercial operation in Europe to launch the California biotech's hemophilia products. Their development deal on hemophilia dates back to the beginning of 2010. And with the $35 million milestone, Ipsen will now own 38% of the U.S. biotech.
The EMA will now review Inspiration's IB1001, a recombinant factor IX product. Another program in development is dubbed OBI-1, an IV porcine recombinant factor VIII--or FVIII--product being developed for the patients with acquired and congenital hemophilia A who have developed inhibitors against human FVIII.
"The filing of IB1001 by the European Medicines Agency is an important step forward in the development of our hemophilia franchise," says Marc de Garidel. "We believe the hemophilia community will positively receive an alternative to the single recombinant Factor IX currently on the market. As we have announced in late August, Ipsen and Inspiration's newly created Hemophilia Business Unit will actively prepare the marketing, medical and regulatory plans prior to the launch of IB1001 in Europe, pending regulatory authorization expected in late 2012."
- here's the press release